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Director Quality EMEA / Qualified Person

Ultragenyx Pharmaceutical Inc.

Quality Assurance

Amsterdam, Netherlands

Posted on May 7, 2025

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Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director Quality / Qualified Person (QP) supports Ultragenyx EMEA Quality Systems and ensures batch certification of our investigational and commercial products in accordance with the principles of current Good Manufacturing Practices and the requirements of the Marketing Authorization.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

Act as Qualified Person, batch certifying investigational and commercial products manufactured by Ultragenyx in accordance with the requirements of the Marketing Authorization or Product Specification file and the principles of current Good Manufacturing Practice (cGMP).
Support Ultragenyx global and regional Quality Management Systems and ensure compliance to applicable GMP and/or GCP regulations.
Lead operational quality initiatives to support regional inspection readiness and maintain compliance with regulatory requirements.
Verify that each batch of medicinal product is distributed under conditions that meet the GDP guidelines according to European GDP-guidelines (GDP Responsible Person).
Contributes to the development and control of quality metrics that predict the performance and health of the quality systems and processes.
Work with cross-functional teams on a global and regional level (Quality Assurance, Quality Control, Regulatory Affairs and Supply Chain) to continuously improve our processes to ensure efficient supply and product quality.
Participate and act as key decision maker in supplier qualification, external audits and self-inspections.

Requirements:

Quality professional with extended experience in biologics and sterile manufacturing and proven project leadership skills in quality and project management.
Minimum of 5 years’ experience as Qualified Person with biologics is required, experience with ATMP (gene therapy) and investigational medicines is preferred.
Master’s degree in pharmacy or (bio-)sciences as defined by EU regulations (Qualified Person)
Fluent in English (written and spoken).
In-depth knowledge of GMP and other applicable regulatory requirements.
Excellent communication skills and collaborative style of working.
Provide clear, direct, and timely verbal and written communication to stakeholders.
Occasional travel to locations within Europe and overseas to support Quality oversight and business needs (5 – 10%). #LI-CK1 #LI-Hybrid

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

· Generous vacation time and public holidays observed by the company

· Volunteer days

· Long term incentive and Employee stock purchase plans or equivalent offerings

· Employee wellbeing benefits

· Fitness reimbursement

· Tuition sponsoring

· Professional development plans

* Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.